NCT01549847撤回3 期
A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Therapeutic Effect of the Association of L-carnitine and Piracetam as an Adjuvant Therapy in the Treatment of Weakness, Muscle Fatigue and Muscle Pain in the Postpoliomyelitis Syndrome
Biolab Sanus Farmaceutica1 个研究点 分布在 1 个国家开始时间: 2012年3月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Changes in fatigue
研究概览
简要总结
This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Postpoliomyelitis Syndrome diagnosis confirmed over a year;
- •Electromyography test compatible with poliomyelitis;
- •Preserved ability to swallow medication;
- •Oral communication ability preserved;
- •Preserved ability to perform pedaling test in at least one lower limb affected by Postpoliomyelitis Syndrome;
- •Ability to understand information about the study and to document the decision about participating in the trial by signing the Informed Consent Form.
排除标准
- •History of intolerance to L-carnitine or piracetam;
- •Treatment with L-carnitine during the past 3 months;
- •Treatment with piracetam or any other nootropics pyrrolidone derivatives, during the past three months;
- •Anemia (hemoglobin reference range - men 13 to 17 g/dL and women 12 to 15 g/dL);
- •High level of glycated hemoglobin (> 7.0%);
- •Electrolyte imbalance (hypokalaemia - reference potassium concentration range: 3.5 to 5.6 mmol / L);
- •Renal failure (creatinine reference range: 0.70 to 1.50 mg/dL);
- •Urinary tract infection;
- •Thyroid dysfunction (reference range: free T4: 0.54 to 0.67 mg/dL and TSH reference range: 0.5 to 5.5 μUI/mL) or usual treatment with thyroid hormone supplementation;
- •Cardiomyopathy;
- •Uncontrolled hypertension;
- •Known or suspected autoimmune disease;
- •Confirmed pregnancy, or plans to get pregnant during the trial;
- •Depression or bipolar affective disorders with moderate to severe episodes within the last twelve months;
- •Insulin-dependent diabetes mellitus;
- •Treatment with anticoagulant drugs over two weeks (including non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, phenprocoumon, heparin);
- •Usual cocaine or alcohol use;
- •Any other condition judged by the investigator as a possibility to interfere on the participant's decision to be part of the study or to accomplish investigation procedures.
研究组 & 干预措施
L-carnitine and piracetam
Experimental
干预措施: L-carnitine and piracetam (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in fatigue
时间窗: 26 weeks
Changes in Muscle Weakness
时间窗: 26 weeks
次要结局
- Changes in daytime sleepiness(26 weeks)
- Changes in quality of life(26 weeks)
- Changes in daily function(26 weeks)
- Changes in depressive mood(26 weeks)
- Changes in oxidative capacity in skeletal muscle(26 weeks)
- Occurrence of adverse events(26 weeks)
- Changes in muscle pain(26 weeks)
研究者
研究点 (1)
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